FDA Product Code QAU: Hemostatic Device For Endoscopic Gastrointestinal Use
Hemostatic Device For Intraluminal Gastrointestinal Use. A Hemostatic Device For Intraluminal Gastrointestinal Use Is A Prescription Device That Is Endoscopically Applied To The Upper And/or Lower Gastrointestinal Tract And Is Intended To Produce Hemostasis Via Absorption Of Fluid Or By Other Physical Means.
Leading manufacturers include 3-D Matrix Europe SAS, Hemostasis, LLC and Nextbiomedical Co., Ltd..
FDA 510(k) Cleared Hemostatic Device For Endoscopic Gastrointestinal Use Devices (Product Code QAU)
About Product Code QAU - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code QAU since 2018, with 9 receiving FDA clearance (average review time: 280 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QAU have taken an average of 139 days to reach a decision - down from 374 days historically, suggesting improved FDA processing for this classification.
QAU devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →